TW201722446A - Antiallergic agent for infants - Google Patents
Antiallergic agent for infants Download PDFInfo
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- TW201722446A TW201722446A TW105133662A TW105133662A TW201722446A TW 201722446 A TW201722446 A TW 201722446A TW 105133662 A TW105133662 A TW 105133662A TW 105133662 A TW105133662 A TW 105133662A TW 201722446 A TW201722446 A TW 201722446A
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- bifidobacterium
- allergic
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- agent
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Abstract
Description
本發明係關於適合乳兒之抗過敏劑及抗過敏用之組合物。 The present invention relates to anti-allergic and anti-allergic compositions suitable for infants.
在現代社會中，為過敏性疾病苦惱的患者數逐漸增加，過敏性疾病可說是現代文明病。作為過敏性之疾病的因子有塵埃或是蟎等的環境因子、食物來源的因子，一旦罹患了過敏性之疾病的情況，就不得不過著從飲食或生活環境中去除過敏因子的生活。作為緩和過敏性之疾病的方法，有投與藥物的藥物療法(非專利文獻1)。 In modern society, the number of patients suffering from allergic diseases is gradually increasing, and allergic diseases can be said to be modernized diseases. As a factor of allergic diseases, there are environmental factors such as dust or cockroaches, and factors of food sources. Once suffering from allergic diseases, it is necessary to live a life of removing allergic factors from the diet or living environment. As a method of alleviating allergic diseases, there is a drug therapy for administering a drug (Non-Patent Document 1).
大多數的過敏性之疾病的部位，有顯著的肥胖細胞聚集及活化的現象。肥胖細胞表現對IgE具有高度親和性的受器，當產生特定的過敏原特異性的IgE時，會引起肥胖細胞的聚集，產生經由過敏原/IgE媒介之肥胖細胞的交聯以及去顆粒作用，而釋放發炎性媒介物。 Most areas of allergic diseases have significant accumulation and activation of obese cells. Obese cells exhibit a high affinity for IgE. When specific allergen-specific IgE is produced, it causes aggregation of obese cells, resulting in cross-linking and degranulation of obese cells via allergen/IgE media. And release inflammatory mediators.
同樣地，與成人相比較，免疫機能尚未發達的乳兒、特別是剛出生不久的乳兒，容易因為塵埃或是蟎等的環境因子、或是食物來源的因子而引發敗血症等感染症，一般以投與抗生素等的藥物作為緩和的方法。 Similarly, compared with adults, infants with undeveloped immune function, especially those born just after birth, are prone to infections such as sepsis due to environmental factors such as dust or mites, or factors of food origin. A drug such as an antibiotic is used as a method of alleviation.
非專利文獻1：「容易理解的藥的知識-知道後安心的用藥方法-」、二宮英編著、新日本法規、平成7年3月22日發行、第379~395頁。 Non-Patent Document 1: "Knowledge of Drugs that Are Easy to Understand - Knowing the Method of Reassuring Medicine" - Edited by Ninomiya, New Japan Law, Issued on March 22, 2007, pages 379-395.
如同非專利文獻1所記載，利用藥物投與緩和過敏性之疾病的方法，雖然對於緩和過敏性之疾病是有效的，但是也有因為投與藥物而造成副作用等的影響，不是絕對有效的方法。 As described in Non-Patent Document 1, a method for alleviating an allergic disease by a drug is effective for alleviating allergic diseases, but it is also an effective method because it affects side effects due to administration of a drug.
特別是對於剛出生不久之乳兒而言，因為投與上述藥物會對之後的成長造成影響。為此，不得不過著不投與上述藥物，而從飲食或生活環境中去除過敏之因子的生活。 Especially for the newly born baby, because the above drugs will affect the subsequent growth. For this reason, it is necessary to live without the above-mentioned drugs, and to remove allergic factors from the diet or living environment.
本發明以提供改善過敏性之疾病、且無副作用之適合於乳兒之抗過敏劑以及抗過敏用組成物為目的。 The present invention has an object of providing an antiallergic agent and an antiallergic composition suitable for an infant, which have an allergic disease and have no side effects.
根據本發明者們深入地調查研究，發現雙岐桿菌屬細菌(雙岐桿菌)對於乳兒、特別是出生後不久之乳兒，具有抗過敏效果，而完成本發明。 According to intensive investigations by the present inventors, it has been found that Bifidobacterium bacteria (Bifidobacterium) have an antiallergic effect on infants, particularly infants born shortly after birth, and have completed the present invention.
亦即，本發明如下所述： That is, the present invention is as follows:
1.一種適合乳兒的抗過敏劑，包括一雙岐桿菌。 1. An anti-allergic agent suitable for infants, including a double bacillus.
2.如前述1所述之適合乳兒的抗過敏劑，其中上述雙岐桿菌為兩叉雙岐桿菌(Bifidobacterium bifidum)。 2. The anti-allergic agent suitable for infants according to the above 1, wherein the Bifidobacterium is Bifidobacterium bifidum.
3.如前述1或2所述之適合乳兒的抗過敏劑，其中上述雙岐桿菌為兩叉雙岐桿菌OLB6378菌株(Bifidobacterium bifidum OLB6378(寄存編號NITE BP-31))。 3. The anti-allergic agent suitable for infants according to the above 1 or 2, wherein the Bifidobacterium is Bifidobacterium bifidum OLB6378 strain (Bifidobacterium bifidum OLB6378 (Accession No. NITE BP-31)).
4.如前述1至3之任一項所述之適合乳兒的抗過敏劑，其中上述雙岐桿菌係為經加熱處理之菌體。 4. The anti-allergic agent suitable for infants according to any one of the above 1 to 3, wherein the Bifidobacterium is a heat-treated cell.
5.如前述1至4之任一項所述之適合乳兒的抗過敏劑，其係每一日108個以上之菌數的上述雙岐桿菌、連續使用1個月以上。 5. The anti-allergic agent suitable for infants according to any one of the above 1 to 4, which is the above-mentioned Bifidobacterium having a bacterial count of 10 8 or more per day for one month or more.
6.一種適合乳兒抗過敏用組成物，其包括前述1至5之任一項所述之抗過敏劑與一糊精。 A composition for a child's anti-allergic composition, which comprises the antiallergic agent and a dextrin according to any one of the above 1 to 5.
7.如前述6所述之適合乳兒抗過敏用組成物，其係為抗過敏用食品組成物。 7. The suitable anti-allergic composition for infants according to the above 6, which is an anti-allergic food composition.
8.一種包裝體，其中前述6至7之任一項所述之適合乳兒抗過敏用組成物於包材內。 A package according to any one of the above 6 to 7, which is suitable for use in a package for the anti-allergic composition of a baby.
[圖1]圖1係為了在說明各組的受試者之懷孕期間(週)及出生體重(g)中並未看見差異的圖。 Fig. 1 is a diagram for not showing differences in pregnancy (week) and birth weight (g) of a subject in each group.
[圖2]圖2係為了說明在各組中之血清中的IgE(μg/100ml)之改變結果的圖。 Fig. 2 is a graph for explaining the results of changes in IgE (μg/100 ml) in serum in each group.
本發明經由找出雙岐桿菌對於乳兒、特別是出生後不久之乳兒，具有抗過敏效果，而可提供一種含有雙岐桿菌、無副作用、適用於乳兒之新抗過敏劑及適用於乳兒之抗過 敏用組成物。 The invention has the anti-allergic effect on the infant, especially the baby after birth, by finding the Bifidobacterium, and provides a new anti-allergic agent containing Bifidobacterium, no side effects, suitable for the baby and suitable for the infant. Over Sensitive composition.
〈雙岐桿菌〉 Bifidobacterium
本發明所使用之雙岐桿菌為屬於雙岐桿菌屬(Bifido Bacterium)之細菌，並不限制其種類或是來源。具體而言、例如，可列舉出兩叉雙岐桿菌(Bifidobacterium bifidum)、長雙岐桿菌(Bifidobacterium longum)、短雙岐桿菌(B.breve)、青春雙岐桿菌(B.adolescentis)、嬰兒雙岐桿菌(B.infantis)、假長雙岐桿菌(B.pseudolongum)、嗜熱雙岐桿菌(B.thermophilum)等雙岐桿菌。 The Bifidobacterium used in the present invention is a bacterium belonging to the genus Bifido Bacterium, and does not limit its kind or source. Specific examples include, for example, Bifidobacterium bifidum, Bifidobacterium longum, B. breve, B. adolescentis, and infants. Bifidobacterium (B. infantis), B. pseudolongum, B. thermophilum, and the like.
具體而言，兩叉雙岐桿菌可列舉出，例如兩叉雙岐桿菌OLB6378菌株(Bifidobacterium bifidum，寄存編號NITE BP-31)，藉由使用上述菌株，可提供本發明之適合乳兒之抗過敏劑。 Specifically, the Bifidobacterium bifidum can be exemplified, for example, by Bifidobacterium bifidum (Accession No. NITE BP-31), and the anti-allergic agent suitable for the present invention can be provided by using the above strain. .
本申請人已將上述菌株寄存於獨立行政法人製品評價技術基盤機構專利微生物寄存中心。以下記載寄存之指定內容。 The applicant has deposited the above-mentioned strains in the patent microbiology deposit center of the independent administrative legal person product evaluation technology base institution. The contents of the registration are described below.
本申請人已依照下述條件將兩叉雙岐桿菌OLB6378菌株(Bifidobacterium bifidum OLB6378)寄存。 The applicant has deposited the Bifidobacterium breve OLB6378 strain (Bifidobacterium bifidum OLB6378) according to the following conditions.
(1)寄存機關名稱：獨立行政法人製品評價技術基盤機構專利微生物寄存中心 (1) Name of the depository institution: Patent Administrative Microbial Depository Center
(2)聯絡方法：郵遞區號292-0818日本國千葉縣木更津市上總鎌足2-5-8 (2) Contact method: Postal code 292-0818, 2-5-8, Kurobe, Kisatsuzu, Chiba Prefecture, Japan
(現：日本國千葉縣木更津市上總鎌足2-5-8 122號室)電話號碼0438-20-5880 (Currently: Room 2-5-8, No. 2-5-8, Kisarazu, Chiba Prefecture, Japan) Phone number 0438-20-5880
(3)寄存編號：NITE BP-31 (3) Deposit number: NITE BP-31
(4)識別名稱：Bifidobacterium bifidum OLB6378 (4) Identification name: Bifidobacterium bifidum OLB6378
(5)原寄存日：2004年10月26日 (5) Original registration date: October 26, 2004
(6)基於布達佩斯條約之寄存移管日：2006年1月18日 (6) Deposit-transfer date based on the Budapest Treaty: January 18, 2006
兩叉雙岐桿菌OLB6378菌株係由人類乳幼兒糞便中分離之格蘭氏陽性專性厭氧性桿菌。將本菌塗佈於BL洋菜培養基(榮研化學股份有限公司)平板上，使用AnaeroPack kenki，(三菱氣體化學股份有限公司)在厭氧環境中，以37℃培養48小時之後，形成不透明之圓形半球狀的具有光澤的菌落。 Bifidobacterium bifidum OLB6378 strain is a Gram-positive obligate anaerobic bacterium isolated from the feces of human infants. This strain was applied to a BL Asian vegetable medium (Eiken Chemical Co., Ltd.) plate, and opaque was formed by using AnaeroPack kenki (Mitsubishi Gas Chemical Co., Ltd.) in an anaerobic environment at 37 ° C for 48 hours. Round hemispherical, glossy colonies.
此外，使用兩叉雙岐桿菌的專一性引子(腸內菌叢研討會8、腸內菌叢之分子生物學性的檢驗、鑑定、光岡知足、松本隆廣)，具體為16S rRNA區域之種間專一性引子，BiBIF-1：CCA CAT GAT CGC ATG TGA TT(序列編號1)、以及BiBIF-2：CCG AAG GCT TGC TCC CAA A(序列編號2)，進行PCR，可得到可認定之PCR產物。並且，對於半乳糖、葡萄糖、果糖、乳糖、龍膽二糖(gentiobiose)具有發酵性。 In addition, the use of the specific primers of Bifidobacterium bifidum (intestinal flora workshop 8, molecular biology test of the intestinal flora, identification, Guanggang contentment, Matsumoto Takahiro), specifically between the 16S rRNA region The specific primer, BiBIF-1: CCA CAT GAT CGC ATG TGA TT (SEQ ID NO: 1), and BiBIF-2: CCG AAG GCT TGC TCC CAA A (SEQ ID NO: 2) were subjected to PCR to obtain a identifiable PCR product. Further, it is fermentable to galactose, glucose, fructose, lactose, and gentiobiose.
作為培養本發明之菌株之培養基，可使用通常使用於雙岐桿菌的培養基。亦即，本發明對可供利用之培養基並無特別限定，除了主碳源之外、只要含有規定範圍含量的氮源、無機物等其他營養素的培養基，可使用任何的培養基。依據所使用的菌種的同化作用，作為碳源可使用乳糖、葡萄糖、蔗糖、果糖、澱粉加水分解物、廢糖蜜等。作為氮源可使用酪蛋白的水解物、乳清蛋白質水解物、大豆蛋白質水解物等含有 有機氮的物質。其他作為增殖促進劑，可使用肉類萃取物、魚肉萃取物、酵母萃取物等。 As the medium for cultivating the strain of the present invention, a medium which is usually used for Bifidobacterium can be used. That is, the medium to be used in the present invention is not particularly limited, and any medium may be used as long as it contains a nutrient medium such as a nitrogen source or an inorganic substance in a predetermined range in addition to the main carbon source. Lactose, glucose, sucrose, fructose, starch hydrolyzate, waste molasses, and the like can be used as the carbon source depending on the assimilation action of the strain to be used. As the nitrogen source, a hydrolyzate of casein, a whey protein hydrolyzate, a soybean protein hydrolyzate, or the like can be used. Organic nitrogen substance. As the proliferation promoter, a meat extract, a fish extract, a yeast extract, or the like can be used.
培養方法較佳為在厭氧條件下進行，可適用通入碳氣體培養等習知的方法、也可以使用通常使用之藉由液體靜止培養等的微好氧條件或是批次培養條件下等其他培養方法。培養溫度為25~50℃、特別是35~42℃為較佳，本發明對此沒有限定，只要是菌可以生長的溫度，也可以使用其他的溫度條件。培養中的培養基的pH值維持在6.0~7.0之間為較佳，只要是菌可以生長的pH值，也可以使用其他的pH條件。培養時間較佳為3~48小時、進而較佳為8~24小時、更佳為10~20小時，只要是菌可以生長的時間，也可以使用其他的培養時間。 The culture method is preferably carried out under anaerobic conditions, and may be applied to a conventional method such as carbon gas culture, or micro aerobic conditions such as static culture using liquid or batch culture conditions. Other culture methods. The culture temperature is preferably 25 to 50 ° C, particularly 35 to 42 ° C. The present invention is not limited thereto, and other temperature conditions may be used as long as the bacteria can grow. It is preferred that the pH of the medium in the culture is maintained between 6.0 and 7.0, and other pH conditions may be used as long as the pH of the culture can be grown. The culture time is preferably from 3 to 48 hours, more preferably from 8 to 24 hours, more preferably from 10 to 20 hours, and other culture time may be used as long as the bacteria can grow.
可將得到的菌體經由下述方法處理後，作為雙岐桿菌處理物，含有於抗過敏劑或是抗過敏用組成物之中。作為雙岐桿菌處理物，包括結束培養後的原本的培養物、結束培養後經過離心分離或是過濾等處理的培養物、上述的濃縮物、進一步加工成糊狀的加工物、依據各種方法獲得之乾燥物(噴霧乾燥物、冷凍乾燥物、真空乾燥物、滾筒乾燥物等)、被分散於媒介之液狀物、由稀釋劑稀釋的稀釋物、加熱處理之後的加熱處理物(加熱處理菌體)、經紫外線及/或放射線處理後之光照射處理物(光照射處理菌體)、經由藥劑(殺菌劑、抗菌劑、靜菌劑)處理之後之藥劑處理物(藥劑處理菌體)、將乾燥物利用研磨機破碎之後的破碎物等。 The obtained cells can be treated as an anti-allergic agent or an anti-allergic composition as a Bifidobacterium-treated material after being treated by the following method. The Bifidobacterium-treated material includes a culture in which the original culture after completion of the culture, a culture which has been subjected to centrifugation or filtration after completion of the culture, the above-mentioned concentrate, and a processed product which is further processed into a paste, and obtained according to various methods. Dry matter (spray dried product, freeze-dried product, vacuum dried product, drum dried product, etc.), liquid substance dispersed in a medium, diluted by a diluent, heat-treated after heat treatment (heat-treated bacteria) a light-irradiated material (light-irradiated cells) treated with ultraviolet rays and/or radiation, a drug-treated product (medicated-treated cells) treated with a drug (bactericide, antibacterial agent, or bacteriostatic agent), The dried product is crushed by a grinder or the like.
離心分離、過濾、濃縮以及破碎等係利用通常使用之方法進行。另外，乾燥可經由例如，真空乾燥、噴霧乾燥、 冷凍乾燥、滾筒乾燥等方法進行。此外、上述之媒介、稀釋劑、以及藥劑(殺菌劑、抗菌劑、靜菌劑)等，可以適當地選用習知的物品來使用。 Centrifugation, filtration, concentration, and crushing are carried out by a commonly used method. In addition, drying can be carried out, for example, by vacuum drying, spray drying, Freeze drying, drum drying, and the like are carried out. Further, the above-mentioned medium, diluent, and pharmaceutical agent (bactericide, antibacterial agent, bacteriostatic agent) and the like can be appropriately selected and used.
本說明書將上述物品簡稱為「雙岐桿菌處理物」或「處理物」。 In the present specification, the above-mentioned article is simply referred to as "Bifidobacterium-treated material" or "treated material".
在本發明中，根據稍後敘述的本發明之實施例可以了解，對於雙岐桿菌，例如即使經80℃、10分鐘加熱處理，而不活性化之菌體，依然具有抗過敏的效果。因此，含有本發明之菌體的處理物，其中所含的菌體不僅是生菌體，即使經加熱處理過後之菌體(例如，從經加熱處理後之雙岐桿菌的懸濁(分散)液中，取0.1ml作為採樣，將其塗抹於含有雙岐桿菌可生長的培養基的培養皿上，在厭氧條件下培養也不會形成雙岐桿菌菌落(colony)形態者)也具有效用。 In the present invention, it can be understood from the examples of the present invention to be described later that, for Bifidobacterium, for example, the cells which are inactivated even after heat treatment at 80 ° C for 10 minutes have an antiallergic effect. Therefore, the treated material containing the bacterial cell of the present invention contains not only the bacterial cell but also the bacterial cell after the heat treatment (for example, suspension (dispersion) of Bifidobacterium from the heat-treated body) In the solution, 0.1 ml was taken as a sample, and it was also applied to a culture dish containing a culture medium in which Bifidobacterium can grow, and cultured under anaerobic conditions did not form a colony of colony (colony).
上述方法得到的雙岐桿菌及/或其處理物，以維持原樣、生菌、或是作為加熱處理菌之後、經過破碎或是未粉碎之處理物、以單獨或是複數種類的混合物可含有於本發明之適合乳兒之抗過敏劑中。 The Bifidobacterium and/or the treated product thereof obtained by the above method may be contained in a mixture of the original sample, the bacteria, or the heat-treated bacteria, after being crushed or unpulverized, and may be contained in a single or plural kinds. The anti-allergic agent suitable for infants of the present invention.
若為生菌，則可期待具有在攝取後在體內(腸內)增殖等的效果。此外，若為加熱處理過後之菌體(例如，從經加熱處理後之雙岐桿菌的懸濁(分散)液中，取0.1ml作為採樣，將其塗抹於含有雙岐桿菌可生長的培養基的培養皿上，在厭氧條件下培養也不會形成雙岐桿菌菌落(colony)形態者)，則不需要考慮雙岐桿菌在有氧環境下難以生存的特性，而可以擴大本發明的適合乳兒的抗過敏劑的應用範圍，因此為較佳。 If it is a fungus, it is expected to have an effect of proliferating in the body (intestine) after ingestion. Further, in the case of the heat-treated bacteria (for example, from the suspension (dispersion) solution of the heat-treated Bifidobacterium, 0.1 ml is taken as a sample, and it is applied to a medium containing Bifidobacterium-grown growth medium. On the culture dish, if the culture is not formed under anaerobic conditions, the shape of the colony is not formed. Therefore, it is not necessary to consider the characteristics that the Bifidobacterium is difficult to survive in an aerobic environment, and the suitable baby of the present invention can be expanded. The range of applications of anti-allergic agents is therefore preferred.
其中之雙岐桿菌特佳為，經加熱處理後為死菌體之加熱處理菌。可推論雙岐桿菌經由加熱處理後，雙岐桿菌的細胞構造等發生改變，容易暴露出成為抗過敏效果原因的物質。 Among them, Bifidobacterium is particularly good, and after heat treatment, it is a heat-treated bacteria of dead cells. It can be inferred that after Bifidobacterium is heated, the cell structure of Bifidobacterium is changed, and it is easy to expose a substance which is a cause of antiallergic effect.
更進一步，雙岐桿菌可使用從培養在培養基中增殖、利用離心分離等方法除去培養基的菌。在上述情形下，藉由不洗淨培養基成分而使其殘留的狀態，使其含有雙岐桿菌之培養物，可更進一步提高本發明的適合乳兒的抗過敏效果。本發明的雙岐桿菌，例如，可購入市售的雙岐桿菌粉末，「明治BifiPure」(明治Food Materia Co.,Ltd.))來使用。 Further, the Bifidobacterium can use a bacterium which is cultured in a culture medium and is removed by a method such as centrifugation. In the above case, the culture of the Bifidobacterium is not removed by washing the medium component, and the anti-allergic effect of the suitable baby of the present invention can be further improved. The Bifidobacterium of the present invention can be used, for example, by purchasing a commercially available Bifidobacterium powder, "Meiji BifiPure" (Meiji Food Materia Co., Ltd.).
作為加熱處理的條件，舉例來說，加熱溫度通常為60~300℃、較佳為60℃~200℃、更佳為60~150℃、進而較佳為60~140℃、進而較佳為60~130℃、進而較佳為60~120℃、進而較佳為60~110℃、進而較佳為60~100℃、進而較佳為70~100℃、進而較佳為70~90℃、特佳為75~85℃。 As the conditions of the heat treatment, for example, the heating temperature is usually 60 to 300 ° C, preferably 60 ° C to 200 ° C, more preferably 60 to 150 ° C, still more preferably 60 to 140 ° C, and still more preferably 60. ~130 ° C, further preferably 60 to 120 ° C, more preferably 60 to 110 ° C, still more preferably 60 to 100 ° C, still more preferably 70 to 100 ° C, still more preferably 70 to 90 ° C, Good for 75~85 °C.
將加熱處理的條件調整為60℃以上，可以殺菌雙岐桿菌的營養細胞，因此較佳。此外，加熱處理的條件設定為300℃以下時，因為雙岐桿菌不會被碳化而能殘留，因此較佳。 It is preferred to adjust the conditions of the heat treatment to 60 ° C or higher to sterilize the vegetative cells of Bifidobacterium. Further, when the conditions of the heat treatment are set to 300 ° C or lower, it is preferable because Bifidobacterium is not carbonized and remains.
且加熱處理的時間為，通常為0.01~120分鐘之間、較佳為0.015~60分鐘之間、更佳為0.02~40分鐘之間、進而較佳為0.025~30分鐘之間、進而較佳為0.03~25分鐘之間、進而較佳為0.03~20分鐘之間。加熱5分鐘以上為特佳。將加熱處理的時間設定為5分鐘以上，可以殺菌雙岐桿菌的營養細胞。此外、將加熱處理的時間設定在120分鐘以內，可以抑制 熱變性且進行更有效率的營養細胞殺菌，因此較佳。 The heat treatment time is usually between 0.01 and 120 minutes, preferably between 0.015 and 60 minutes, more preferably between 0.02 and 40 minutes, further preferably between 0.025 and 30 minutes, and further preferably. It is between 0.03 and 25 minutes, and more preferably between 0.03 and 20 minutes. Heating for more than 5 minutes is especially good. By setting the heat treatment time to 5 minutes or more, vegetative cells of Bifidobacterium can be sterilized. In addition, setting the heat treatment time to within 120 minutes can suppress It is preferred to heat denature and perform more efficient vegetative cell sterilization.
當利用低溫度範圍(60~100℃)進行加熱處理時，最適當的加熱時間為，例如0.2~120分鐘之間、較佳為0.2~60分鐘之間、更佳為0.2~40分鐘之間、進而較佳為0.2~30分鐘之間、進而較佳為0.2~25分鐘之間、特佳為0.2~20分鐘之間。 When the heat treatment is carried out using a low temperature range (60 to 100 ° C), the most suitable heating time is, for example, between 0.2 and 120 minutes, preferably between 0.2 and 60 minutes, more preferably between 0.2 and 40 minutes. Further preferably, it is between 0.2 and 30 minutes, further preferably between 0.2 and 25 minutes, and particularly preferably between 0.2 and 20 minutes.
此外，當利用高溫度範圍(100~300℃)進行加熱處理時，最適當的加熱時間為，例如0.01~0.5分鐘之間、較佳為0.015~0.5分鐘之間、更佳為0.02~0.5分鐘之間、進而較佳為0.025~0.5分鐘之間、進而較佳為0.03~0.5分鐘之間、特佳為0.03~0.5分鐘之間。 Further, when heat treatment is performed using a high temperature range (100 to 300 ° C), the most appropriate heating time is, for example, 0.01 to 0.5 minutes, preferably 0.015 to 0.5 minutes, more preferably 0.02 to 0.5 minute. Further, it is preferably between 0.025 and 0.5 minutes, more preferably between 0.03 and 0.5 minutes, and particularly preferably between 0.03 and 0.5 minutes.
例如，雙岐桿菌的加熱處理，較佳為80℃、10分鐘，或者是90℃、15秒的條件進行。 For example, the heat treatment of Bifidobacterium is preferably carried out at 80 ° C for 10 minutes or at 90 ° C for 15 seconds.
加熱處理的方法並無特別的限定。例如可以將得到的菌體利用板式殺菌機、管式殺菌機、直接加熱式殺菌機、電熱式槽等加熱殺菌裝置，依照規定的條件進行加熱。 The method of heat treatment is not particularly limited. For example, the obtained cells can be heated in accordance with predetermined conditions using a heat sterilization device such as a plate sterilizer, a tube sterilizer, a direct heating sterilizer, or an electric heating tank.
為了發揮本發明之適合乳兒的抗過敏效果，應攝取的雙岐桿菌量為，依照較佳的順序為，例如，相當於一天108個以上、108~1012個、5 x 108~5 x 1011個、109~1011個、5 x 109~5 x 1010個、6 x 109~4 x 1010個、7 x 109~3 x 1010個。更佳為8 x 109~2 x 1010個，進而較佳為9 x 109~2 x 1010個。 In order to exert the anti-allergic effect of the present invention suitable for infants, the amount of Bifidobacterium to be ingested is, in order, for example, equivalent to 10 8 or more, 10 8 to 10 12 , 5 x 10 8 ~ 5 x 10 11 , 10 9 ~ 10 11 , 5 x 10 9 ~ 5 x 10 10 , 6 x 10 9 ~ 4 x 10 10 , 7 x 10 9 ~ 3 x 10 10 . More preferably, it is 8 x 10 9 ~ 2 x 10 10 pieces, and further preferably 9 x 10 9 ~ 2 x 10 10 pieces.
根據上述範圍，可以達到實際上適合乳兒之抗過敏效果。此外，亦發現本發明之適合乳兒之抗過敏劑具有預防及治療之奏效成分，亦即有效成分，只要是可以發揮其效果之型態，對其使用目的並無限制。 According to the above range, an anti-allergic effect which is actually suitable for the baby can be achieved. Further, it has been found that the anti-allergic agent suitable for infants of the present invention has an active ingredient for prevention and treatment, that is, an active ingredient, and is not limited as long as it can exert its effect.
另外，本發明之抗過敏劑(以下稱為「本發明之劑」)，因為副作用少，即使是乳兒、特別是剛出生後不久之乳兒，也可連續攝取。為了發揮適合乳兒之抗過敏效果，本發明之雙岐桿菌之攝取期間，較佳之順序為，例如，一個月以上、1~12個月、1~10個月、1~9個月、1~8個月、2~7個月。 Further, the anti-allergic agent of the present invention (hereinafter referred to as "the agent of the present invention") can be continuously ingested even if it is a baby, especially a baby just after birth, because the side effects are small. In order to exert an anti-allergic effect suitable for infants, the preferred period of ingestion of the Bifidobacterium of the present invention is, for example, one month or more, 1 to 12 months, 1 to 10 months, 1 to 9 months, 1~ 8 months, 2~7 months.
遵照上述範圍的雙岐桿菌的攝取時間，實際上，可以達到適合乳兒之抗過敏效果。特別是將相當於一天108以上的菌數的雙岐桿菌，連續使用一個月以上為較佳，相當於一天1010以上的菌數的雙岐桿菌，連續使用一個月以上為更佳。 According to the above-mentioned range of the intake time of the Bifidobacterium, in fact, an anti-allergic effect suitable for the baby can be achieved. In particular, Bifidobacterium which is equivalent to a number of bacteria of 10 8 or more per day is preferably used continuously for one month or more, and is equivalent to a Bifidobacterium having a number of bacteria of 10 10 or more per day, and it is more preferably used continuously for one month or more.
在本說明書中所稱之乳兒為出生之後、未滿一歲之嬰兒。例如，0個月齡~6個月齡時的嬰兒。更詳細而言，包括健康嬰兒、發育未成熟嬰兒、早產兒以及低出生體重嬰兒。在本發明中，對於嬰兒的種並沒有特別限定，包含人類。 The baby referred to in this specification is an infant who is less than one year old after birth. For example, infants from 0 months to 6 months of age. More specifically, it includes healthy babies, immature babies, premature babies, and low birth weight babies. In the present invention, the species of the baby is not particularly limited and includes humans.
本發明之適合乳兒之抗過敏劑及抗過敏用組成物，經由給與乳兒，特別是從出生後不久之乳兒即開始攝取(投與)，之後也繼續攝取(投與)，而證實具有過敏之預防及治療的效果。具體而言，本發明證實攝取(投與)與未攝取(投與)本發明之適合乳兒之抗過敏劑及抗過敏用組成物的情況相比，血清中之IgE有顯著性的減少。 The anti-allergic agent and the anti-allergic composition suitable for the infant of the present invention are ingested (administered) by the administration of the milk, especially from the baby immediately after birth, and then continue to be ingested (administered), and it is confirmed to be allergic. The effect of prevention and treatment. Specifically, the present invention confirmed that there was a significant decrease in IgE in serum as compared with the case of ingestion (administration) of an anti-allergic agent and an anti-allergic composition suitable for infants of the present invention.
亦即，經由攝取(投與)本發明之適合乳兒之抗過敏劑及其抗過敏用組成物，可在無副作用的狀態下，對出生後不久之乳兒賦予其抗過敏作用，可期待即使在之後的成長過程中也具有上述抗過敏作用，因此可以解決及/或緩和被迫過著從飲食或是生活環境中除去過敏因子的生活所造成的生活不便。 In other words, by ingesting (administering) the anti-allergic agent suitable for the baby of the present invention and the anti-allergic composition thereof, the anti-allergic effect can be imparted to the baby after birth without side effects, and it is expected that even in the case of The anti-allergic effect is also present during the subsequent growth, so that it is possible to solve and/or alleviate the inconvenience caused by living forced to remove allergic factors from the diet or the living environment.
出生後不久的乳兒的免疫機能處於尚未發達的狀態，此時攝取本發明之抗過敏劑及抗過敏用組成物，可以達到早期的抗過敏效果，特別是對於容易遭受感染或是罹患過敏疾病的低出生體重嬰兒，賦予其抗過敏作用，可期待在之後的成長過程中，也具有上述的抗過敏作用，因此可以解決及/或緩和被迫過著從飲食或是生活環境中除去過敏因子的生活而造成的生活不便。 The immune function of the baby after birth is in an undeveloped state. At this time, the anti-allergic agent and the anti-allergic composition of the present invention can be used to achieve an early anti-allergy effect, especially for an infection or an allergic disease. Low-birth-weight infants are given anti-allergic effects and can be expected to have the above-mentioned anti-allergic effects in the subsequent growth process, so that they can be solved and/or alleviated by being forced to remove allergic factors from the diet or living environment. Life caused by life is inconvenient.
於此所述之出生後不久之乳兒為例如，出生後0~60天、0~50天、0~40天、0~30天、0~20天、0~15天、0~10天等。另外，於此所述之低出生體重嬰兒為，人類的情況為，出生時體重為300~3000g、350~2900g、400~2800g、450~2700g、500~2600g、500~2500g。 The baby born shortly after this is, for example, 0 to 60 days after birth, 0 to 50 days, 0 to 40 days, 0 to 30 days, 0 to 20 days, 0 to 15 days, 0 to 10 days, etc. . In addition, the low birth weight infants described herein are humans having a body weight of 300 to 3000 g, 350 to 2900 g, 400 to 2800 g, 450 to 2700 g, 500 to 2600 g, and 500 to 2500 g at birth.
本發明之劑可作為單劑使用，或是可與其他成分混合，作為本發明之適合乳兒之抗過敏用組成物(以下稱為「本發明之組成物」)使用。本發明之劑的上述組成物的配合量，因應其目的、用途、型態、劑型、症狀及體重等可以任意地決定。此外，組成物也可替換讀為劑。 The agent of the present invention can be used as a single agent or can be mixed with other components and used as an anti-allergic composition suitable for an infant of the present invention (hereinafter referred to as "the composition of the present invention"). The compounding amount of the above-mentioned composition of the agent of the present invention can be arbitrarily determined depending on the purpose, use, form, dosage form, symptoms, body weight and the like. In addition, the composition can also be substituted for a reading agent.
本發明對本發明之劑的含量並無限定，作為本發明之劑的含量，相對於全體組成物，可以0.001~90%(w/w)的含量配合，更佳為可以0.001~50%的含量配合。根據前述範圍，可方便攝取(投與)。 The content of the agent of the present invention is not limited, and the content of the agent of the present invention may be 0.001 to 90% (w/w), more preferably 0.001 to 50%, based on the total composition. Cooperate. According to the foregoing range, it is convenient to ingest (administer).
本發明之劑或本發明之組成物可為經口投與及非經口投與(肌肉內、皮下、靜脈內、塞劑及經皮等)之任何一種投與皆可。此外，本發明之劑或本發明之組成物不會被因投與 藥劑而引起的副作用所影響，而可以投與。更進一步，本發明之劑或本發明之組成物在改善腹瀉症狀、改善便秘症狀、抑制腸內有害細菌的增殖、產生維生素B群、幫助乳糖分解而促進消化吸收的同時，也達到抗過敏效果。 The agent of the present invention or the composition of the present invention may be administered by any of oral administration and parenteral administration (intramuscular, subcutaneous, intravenous, sessile, transdermal, etc.). Furthermore, the agent of the invention or the composition of the invention will not be administered It can be affected by the side effects caused by the drug. Furthermore, the agent of the present invention or the composition of the present invention can also improve the symptoms of diarrhea, improve the symptoms of constipation, inhibit the proliferation of harmful bacteria in the intestine, produce vitamin B group, help lactose to decompose and promote digestion and absorption, and also achieve anti-allergy effect. .
具體而言，本發明之劑或本發明之組成物可為醫藥品或是飲食品之任一形式。例如，作為醫藥品而直接投與、或是作為特定保健用食品等之特別用途食品或營養品而直接攝取，可以發揮預期的抗過敏效果。另外，作為特別用途食品或是營養食品的例子，可為，調製奶粉、流質食品、患者用食品、乳兒用調製奶粉、幼兒用奶粉等食品、哺乳婦女用奶粉等食品、補充品、營養強化食品等。 Specifically, the agent of the present invention or the composition of the present invention may be in any form of a pharmaceutical or a food or drink. For example, it can be directly ingested as a pharmaceutical product, or directly taken as a special-purpose food or nutrient such as a specific health food, and can exert an anti-allergic effect as expected. In addition, as an example of a special-purpose food or a nutritious food, foods, supplements, and fortified foods such as milk powder, liquid food, patient food, milk powder for infants, milk powder for infants, milk powder for breastfeeding women, and nutritional supplement foods may be prepared. Wait.
本發明之劑作為醫藥品使用的情況，以形態而言，例如，錠劑、包衣錠劑、膠囊、顆粒劑、散劑、溶液、糖漿、乳劑等的製劑可利用經口投與而給與。上述提到的各種製劑，可經由常法，將主要藥物成分的本發明之菌體及/或處理物與分散劑、賦形劑、結合劑、崩壞劑、潤滑劑、著色劑、矯味矯臭劑、溶解輔助劑、懸濁劑、披覆用劑等，醫藥的製劑技術領域之通常使用的習知的佐劑以進行製劑化，成為含有抗過敏用組成物之經口製劑。 When the agent of the present invention is used as a pharmaceutical product, for example, a preparation such as a tablet, a coated tablet, a capsule, a granule, a powder, a solution, a syrup, or an emulsion can be administered by oral administration. . The various preparations mentioned above may be used to disperse the main drug component of the present invention by a fungicide, an excipient, a binding agent, a disintegrating agent, a lubricant, a coloring agent, and a flavoring agent. A conventional adjuvant used in the field of pharmaceutical preparation technology for pharmaceutical preparation, a dissolution aid, a suspending agent, a coating agent, etc., is formulated into an oral preparation containing an antiallergic composition.
其中，將本發明之劑與分散劑混合後，作為組成物使用較佳。作為分散劑，可列舉出，例如，酪蛋白等乳蛋白質、大豆蛋白質、胜肽、胺基酸、澱粉、糊精、聚木糖、寡糖、醣類(葡萄糖、乳糖、蔗糖、半乳糖、麥芽糖)、糖醇(海藻糖、木糖醇、木藻糖醇、巴拉金糖、海藻酮糖、木糖)。分散劑之 中，特別以糊精為較佳。使用糊精作為分散劑可使粉末得以造粒、使分散溶解等的操縱變得容易、並且可以長期保存。 Among them, after mixing the agent of the present invention and a dispersing agent, it is preferably used as a composition. Examples of the dispersant include milk protein such as casein, soybean protein, peptide, amino acid, starch, dextrin, polyxylose, oligosaccharide, and saccharide (glucose, lactose, sucrose, galactose, Maltose), sugar alcohol (trehalose, xylitol, xylitol, palatinose, trehalulose, xylose). Dispersing agent Among them, dextrin is preferred. The use of dextrin as a dispersing agent enables the powder to be granulated, easy to disperse and dissolve, and the like, and can be stored for a long period of time.
分散劑、特別是糊精的形狀以顆粒狀較佳。顆粒狀不僅僅增加溶解性，因為其填充性能高，所以可分裝成少量包裝。此外，也不會在落入包裝材料的過程中，就造成因分裝而產生的質量分布不平均，而能夠正確的分裝，具有製造上的優點。 The shape of the dispersant, especially the dextrin, is preferably in the form of particles. Granularity not only increases solubility, but because of its high filling properties, it can be dispensed into small packages. In addition, in the process of falling into the packaging material, the mass distribution due to the dispensing is not uniform, and the dispensing can be correctly performed, which has manufacturing advantages.
本發明的組成物中、本發明之劑與分散劑的質量比為，1：100~1：2為較佳、更佳為1：100~1：10、進而較佳為1：100~1：20。經由本發明之劑與分散劑的質量比為上述範圍，本發明之抗過敏劑可以達到有效率的分散。 In the composition of the present invention, the mass ratio of the agent of the present invention to the dispersing agent is preferably 1:100 to 1:2, more preferably 1:100 to 1:10, and still more preferably 1:100 to 1. :20. The mass ratio of the agent to the dispersant of the present invention is in the above range, and the antiallergic agent of the present invention can achieve efficient dispersion.
舉例而言，將含有本發明之劑與糊精的本發明之組成物利用經口投與的情況，將本發明之組成物依照所訂份量細分，包裝在包材內作為包裝體後而投與。在本發明中，較佳為包裝成一次使用的分量，及包裝成一次使用複數個的分量，包裝成一次使用的份量為更佳。 For example, when the composition of the present invention containing the agent of the present invention and dextrin is administered orally, the composition of the present invention is subdivided according to the amount of the package, and is packaged in the package as a package. versus. In the present invention, it is preferable to package the components into one use, and package them into a plurality of components at a time, and it is more preferable to package them in a single use.
將本發明之劑及組成物添加至無副作用之食品組成物時的情況，可經由添加於各種飲食品(牛奶、清涼飲料、優酪乳、優格、起司、麵包、餅乾、蘇打餅乾、披薩餅、調製奶粉、流質食品、患者用食品、乳兒用調製奶粉、幼兒用奶粉等食品、哺乳婦女用奶粉等食品、營養食品等)中而攝取。本發明之劑及本發明之組成物可直接使用，也可與其他食品或食品成分混合使用，可利用通常的食品組成物的習知方法而使用。此外，關於其性狀，以通常使用於飲食品的狀態，例如， 固體狀(粉末、顆粒狀或其他)、糊狀、液體或懸濁狀的其中任何一種皆可。採取上述的形態，可以在不會感到心理障礙的情況下攝取本發明之劑。 When the agent and the composition of the present invention are added to a food composition having no side effects, it can be added to various foods and drinks (milk, refreshing drink, yogurt, yoghurt, cheese, bread, biscuit, soda cracker, Ingested in pizza cakes, prepared milk powder, liquid foods, patient foods, milk powder for infants, milk powder for infants, foods for breastfeeding women, milk powder, etc. The agent of the present invention and the composition of the present invention can be used as it is, or can be used in combination with other foods or food ingredients, and can be used by a conventional method of a usual food composition. In addition, regarding its trait, it is usually used in the state of foods and drinks, for example, Any of a solid (powder, granule or other), paste, liquid or suspension may be used. By adopting the above form, the agent of the present invention can be ingested without feeling a psychological disorder.
此外，本發明之劑或組成物也可與無副作用之水、蛋白質、糖質、脂質、維生素類、礦物質類、有機酸、有機鹼、果汁、風味類等混合後，作為組合物使用。 Further, the agent or composition of the present invention may be used as a composition by mixing with water, protein, saccharide, lipid, vitamins, minerals, organic acids, organic bases, fruit juices, flavors and the like without side effects.
作為蛋白質類，可以列舉出例如全脂奶粉、脫脂奶粉、部分脫脂奶粉、酪蛋白、乳清粉、乳清蛋白質、乳清蛋白質濃縮物、乳清蛋白質分離物、α酪蛋白、β酪蛋白、κ酪蛋白、β乳球蛋白、α乳白蛋白、乳鐵蛋白、大豆蛋白質、雞蛋蛋白質、肉蛋白質等動植物性蛋白質、上述之水解物；奶油、乳性礦物質、鮮乳油、乳清、非蛋白態氮、涎酸、磷脂、乳糖等各種乳來源成分。具有作為醫藥品及飲食品的使用實績、無副作用的品項全部可以適用。此外，可將上述的成分組合兩種以上使用。 Examples of the protein include, for example, whole milk powder, skimmed milk powder, partially skimmed milk powder, casein, whey powder, whey protein, whey protein concentrate, whey protein isolate, alpha casein, and beta casein. Phytoplasmic protein such as κ casein, β-lactoglobulin, α-lactalbumin, lactoferrin, soy protein, egg protein, meat protein, hydrolysate as described above; cream, milk mineral, fresh cream, whey, non-protein Various milk-derived components such as nitrogen, citric acid, phospholipids, and lactose. All items that have been used as pharmaceuticals and foods and have no side effects can be applied. Further, two or more of the above components may be used in combination.
作為糖質，可列舉出例如，糖類、加工澱粉(除了糊精之外、可溶性澱粉、英國澱粉、氧化澱粉、澱粉酯、澱粉醚等)、食物纖維等。 Examples of the saccharide include saccharides, processed starch (other than dextrin, soluble starch, British starch, oxidized starch, starch ester, starch ether, etc.), dietary fiber, and the like.
作為脂質，可列舉出例如，豬油、魚油等，上述的分餾油、氫化油、酯交換油等動物性油脂；棕櫚油、紅花油、玉米油、菜籽油、椰子油，上述的分餾油、氫化油、酯交換油等植物性油脂等。 Examples of the lipid include lard oil, fish oil, and the like, animal fats such as the above-mentioned fractionated oil, hydrogenated oil, and transesterified oil; palm oil, safflower oil, corn oil, rapeseed oil, and coconut oil, and the above-mentioned fractionated oil. And vegetable oils such as hydrogenated oil and transesterified oil.
作為維生素類，可列舉出例如，維生素A、胡蘿蔔素類、維生素B群、維生素C、維生素D群、維生素E、維生 素K群、維生素P、維生素Q、菸鹼、菸鹼酸、泛酸、生物素、肌醇、膽鹼、葉酸等。 Examples of the vitamins include vitamin A, carotenes, vitamin B group, vitamin C, vitamin D group, vitamin E, and vitamins. K group, vitamin P, vitamin Q, nicotine, niacin, pantothenic acid, biotin, inositol, choline, folic acid, etc.
作為礦物質，可列舉出例如，鈣、鉀、鎂、鈉、銅、鐵、錳、鋅、硒等。 Examples of the mineral include calcium, potassium, magnesium, sodium, copper, iron, manganese, zinc, selenium, and the like.
作為有機酸，可列舉出例如，蘋果酸、檸檬酸、乳酸、酒石酸等。具有作為醫藥品及飲食品的使用實績、無副作用的品項全部可以適用。此外，可將上述的成分組合兩種以上使用。 Examples of the organic acid include malic acid, citric acid, lactic acid, tartaric acid, and the like. All items that have been used as pharmaceuticals and foods and have no side effects can be applied. Further, two or more of the above components may be used in combination.
將本發明之劑或本發明之組成物作為食品或藥劑提供的情況，其製造方法可使用當領域業者的習知技術進行。當領域之業者將本發明之雙歧桿菌或處理物與其他成分之混合工程、成形工程、殺菌工程、發酵工程、燒成工程、乾燥工程、冷卻工程、造粒工程以及包裝工程等，經過適當地組合後，可以製造出所期望的食品或是藥劑。 In the case where the agent of the present invention or the composition of the present invention is provided as a food or a medicament, the production method thereof can be carried out using a conventional technique of a person in the field. When the industry practitioners combine the bifidobacteria or the treatment of the present invention with other components, forming engineering, sterilization engineering, fermentation engineering, firing engineering, drying engineering, cooling engineering, granulation engineering, and packaging engineering, etc., After combination, the desired food or medicament can be produced.
更進一步，本發明之劑以及本發明之組成物也可適用於保健機能食品或是病患用食品。保健機能食品的制度變更為與之前的特定保健用食品制度進行整合，其設定的對象不僅是通常的食品，連錠劑、膠囊等形狀的食品也可作為適用對象，因此有特定保健用食品(個別許可型)與營養機能食品(規格基準型)兩種種類。藉由直接攝取含有本發明之劑或本發明之組成物的特定保健用食品等的特別用途食品或是營養機能食品，可以期待發揮抗過敏效果。 Further, the agent of the present invention and the composition of the present invention are also applicable to a health functional food or a food for a patient. The health-care food system is changed to be integrated with the previous special health food system, and the target is not only the normal food, but also foods such as tablets and capsules. There are two types of individual licensed types and nutritional functional foods (standard type). The anti-allergic effect can be expected to be exerted by directly ingesting a special-purpose food or a nutritious functional food containing a specific health food or the like containing the agent of the present invention or the composition of the present invention.
作為將本發明之劑以及本發明之組成物添加至調製奶粉的情況，其形態可列舉出，例如乳兒用調製奶粉、胜肽 奶、補充奶、成長奶、低出生體重嬰兒用調製奶粉、無乳糖奶粉、低鈉特殊奶粉及母乳添加用粉末等乳兒用的抗過敏用的經口組成物，只要是能夠期待本發明之效果、效能的物品，並無特殊限制。本發明之劑及本發明之組成物，除了調製奶粉之外，也可以加入其他食品中並無特別限制。例如，優格或點心類。 As a case where the agent of the present invention and the composition of the present invention are added to a prepared milk powder, the form thereof may, for example, be a milk powder for a baby, a peptide An anti-allergic oral composition for milk, milk, milk, milk for growth, low-birth-weight infant formula, lactose-free milk powder, low-sodium special milk powder, and powder for breast milk addition, as long as the effect of the present invention can be expected There are no special restrictions on the items of performance. The agent of the present invention and the composition of the present invention may be added to other foods in addition to the milk powder, and are not particularly limited. For example, yoghurt or snacks.
本發明之有效成分之雙歧桿菌可做為醫藥組成物、或是飲食中常用且預期無副作用之飲食品或是可以做為添加劑，加入預期有抗過敏之組成物，可以經口或是經管攝取。 The bifidobacterium which is an active ingredient of the present invention can be used as a pharmaceutical composition, a food or drink which is commonly used in a diet and is expected to have no side effects, or can be used as an additive, and is added to an anti-allergic composition, which can be administered orally or administered. Ingestion.
本發明之有效成分之雙歧桿菌，不僅限於人類，對於哺乳動物(哺乳類)也顯示具有上述之優異的效果、效能。因此，本發明可作為含有雙歧桿菌有效成分的飼料及飼料添加劑，特別是飼育哺乳動物用之奶粉及奶粉添加劑。 The bifidobacterium which is an active ingredient of the present invention is not limited to humans, and exhibits excellent effects and potency as described above for mammals (mammals). Therefore, the present invention can be used as a feed and feed additive containing an active ingredient of bifidobacteria, particularly a milk powder and a milk powder additive for breeding mammals.
以下，根據本發明之實施例以及比較例的實驗結果，對本發明做更詳細的說明。但是，本發明之範圍不受限於所述之實施例。 Hereinafter, the present invention will be described in more detail based on experimental results of the examples of the present invention and comparative examples. However, the scope of the invention is not limited to the embodiments described.
[實施例1](本發明之組成物(加熱處理)的製備) [Example 1] (Preparation of composition (heat treatment) of the present invention)
a)經加熱處理的OLB6378菌株的冷凍乾燥粉末的製備 a) Preparation of freeze-dried powder of heat-treated OLB6378 strain
將兩叉雙岐桿菌OLB6378菌株(Bifidobacterium bifidum OLB6378(寄存號碼NITE BP-31))的原菌末(生菌數3.9 x 1011cfu/g，商品名「明治BifiPure(登錄商標)」，明治Food Materia Co.,Ltd.)350g加入調整為45℃的原料水3,500ml中，進行攪拌至完全懸濁。之後，在攪拌過程中加溫，80℃維持10分鐘， 之後進行冷卻。將得到的加熱菌體的懸濁液進行冷凍乾燥，可獲得300g經加熱處理的OLB6378菌株的凍結乾燥粉末。並且，經加熱處理後的OLB6378菌株，培養在MRS洋菜平板培養基上後，未見雙岐桿菌之生菌。此外，獲得的OLB6378菌株的凍結乾燥粉末300g中，概算有1.37 x 1014個雙歧桿菌(3.9 x 1011(cfu/g) x 350(g)=1.37 x 1014cfu)。熱處理之後的菌的菌數，以換算成生菌數(cfu)的方法表示。 The original bacterium of the Bifidobacterium bifidum OLB6378 strain (Bifidobacterium bifidum OLB6378 (registered number NITE BP-31)) (the number of bacteria is 3.9 x 10 11 cfu/g, the trade name "Meiji BifiPure (registered trademark)", Meiji Food 350 g of Materia Co., Ltd.) was added to 3,500 ml of raw material water adjusted to 45 ° C, and stirred until completely suspended. Thereafter, the mixture was heated during the stirring, maintained at 80 ° C for 10 minutes, and then cooled. The suspension of the obtained heated cells was freeze-dried to obtain 300 g of a freeze-dried powder of the heat-treated OLB6378 strain. Further, after the heat-treated OLB6378 strain was cultured on the MRS agar medium plate medium, no bacteria of Bifidobacterium were found. Further, in 300 g of the freeze-dried powder of the obtained OLB6378 strain, there were estimated 1.37 x 10 14 Bifidobacteria (3.9 x 10 11 (cfu/g) x 350 (g) = 1.37 x 10 14 cfu). The number of bacteria of the bacteria after the heat treatment is expressed by a method of converting the number of bacteria to the number of bacteria (cfu).
b)本發明之組成物(加熱處理)的製備 b) Preparation of the composition of the invention (heat treatment)
加熱處理後之OLB6378菌株的凍結乾燥粉末120g與顆粒糊精(松谷化學公司)2880g均勻混合，分裝成0.5g之後，成為本發明之組成物。本發明之組成物概算含有9.13 x 109個雙歧桿菌(1.37 x 1014(cfu) x [120(g)/300(g)] x [0.5(g)/3000(g)]=9.13 x 109cfu)。熱處理之後的菌的菌數，以換算成生菌數(cfu)的方法表示。 120 g of the freeze-dried powder of the OLB6378 strain after the heat treatment was uniformly mixed with 2,880 g of particulate dextrin (Songu Chemical Co., Ltd.), and after being dispensed into 0.5 g, it became a composition of the present invention. The estimated composition of the present invention contains 9.13 x 10 9 Bifidobacteria (1.37 x 10 14 (cfu) x [120(g)/300(g)] x [0.5(g)/3000(g)] = 9.13 x 10 9 cfu). The number of bacteria of the bacteria after the heat treatment is expressed by a method of converting the number of bacteria to the number of bacteria (cfu).
[實施例2](本發明之組成物(生菌)的製備) [Example 2] (Preparation of composition (probiotic) of the present invention)
將實施例1中的OLB6378菌的原菌菌末(生菌數3.9 x 1011cfu/g)120g與顆粒糊精(松谷化學公司)2880g均勻混合，分裝成0.5g之後，成為本發明之組成物。本發明之組成物，概算約具有9.13 x 109cfu個菌數的雙歧桿菌。 120 g of the original bacteria (3.9 x 10 11 cfu/g) of the OLB6378 strain in Example 1 and 2880 g of the granular dextrin (Songu Chemical Co., Ltd.) were uniformly mixed and distributed into 0.5 g, and then the present invention was used. Composition. The composition of the present invention is estimated to have a Bifidobacterium having a bacterial count of 9.13 x 10 9 cfu.
[試驗例1] [Test Example 1]
在試驗例1中，將攝取實施例1的本發明的組成物(加熱菌)的受試者組別稱為「組成物(加熱菌)攝取組」，攝取實施例2的本發明之組成物(生菌)的受試者組別稱為「組成物(生菌)攝取組」，不進行介入的受試者組別稱為「對照(未投與)組」。 作為受試者群，由懷孕週數為30~38週之低出生體重嬰兒(出生時體重2500g以下)中，選定人數分別為組成物(加熱菌)組24名，組成物(生菌)組29名，對照(未投與)組29名。組成物(加熱菌)組給予實施例1之b的組成物(加熱菌)，組成物(生菌)組給予實施例2的組成物(生菌)，兩組皆一日兩回分別投與。組成物(加熱菌)組、組成物(生菌)組各組皆在出生後48小時之內開始初次攝取，攝取期間為6個月。並且，如圖1所示，受試者的懷孕期間及出生體重，在各組別之間並未見到差異。 In Test Example 1, the subject group in which the composition (heating bacteria) of the present invention of Example 1 was ingested was referred to as a "composition (heating bacteria) ingestion group", and the composition of the present invention of Example 2 was ingested ( The subject group of the "bacteria" is referred to as a "composition (bacteria) ingestion group", and the subject group not subject to intervention is referred to as a "control (unsubjected) group". As a subject group, the number of selected low-birth-weight babies (when the birth weight is 2,500 g or less) in the number of weeks of pregnancy is 24 in the composition (heating bacteria) group, and the composition (bacteria) group 29 patients, 29 in the control (unpaid) group. The composition (heated bacteria) group was given the composition of Example 1 b (heated bacteria), and the composition (bacteria) group was given the composition of Example 2 (bacteria), and both groups were administered twice a day. . Each of the composition (heated bacteria) group and the composition (probiotic) group was initially ingested within 48 hours after birth, and the ingestion period was 6 months. Further, as shown in Fig. 1, no differences were observed between the groups during pregnancy and birth weight.
各組別皆在0個月齡、1個月齡、2個月齡、6個月齡時，採取受試者的血液，測定血清中的IgE。血清IgE的測定，係利用JCA-BM6070自動分析裝置(JEOL公司製作)，根據濁度測定法進行。其結果如圖2所示。 The blood of the subject was taken at 0 months, 1 month, 2 months, and 6 months of age, and IgE in the serum was measured. The measurement of serum IgE was carried out by a turbidity measurement method using a JCA-BM6070 automatic analyzer (manufactured by JEOL Co., Ltd.). The result is shown in Figure 2.
如圖2所示，在6個月齡中，血清中的IgE的增加為，組成物(加熱菌)組與對照(未投與)組相比較，顯著地被抑制。從上述結果可以明瞭，本發明之組成物(特別是本發明之組成物(加熱菌))對乳兒，特別是出生後不久之低出生體重嬰兒的抗過敏效果是有效的。 As shown in Fig. 2, at 6 months of age, the increase in IgE in the serum was significantly suppressed in the composition (heated bacteria) group as compared with the control (unadministered) group. From the above results, it is understood that the composition of the present invention (especially the composition of the present invention (heating bacteria)) is effective for the antiallergic effect of the infant, especially the low birth weight infant shortly after birth.
雖然使用特定的樣態以詳細說明本發明，但該領域人員應明白將其變更及變形仍不脫離本發明之意圖及範圍。另外，本申請係基於2015年10月19日向日本特許廳提出申請(特願2015-205950)的優先權，其中所述整體引入本作為參考。 While the invention has been described in detail, it is understood that the invention In addition, the present application is based on the priority of Japanese Patent Application No. 2015-205950, the entire disclosure of which is hereby incorporated by reference.
使用本發明之適合乳兒的抗過敏劑或抗過敏用組 成物，可期待在無副作用的狀態下，達到預防或治療過敏性疾病的效果，特別是可預防出生後不久之乳兒的過敏症的同時，從乳兒的發育及成長的觀點而言，也可有效的促進其發育成長。 Use of the anti-allergic or anti-allergy group suitable for infants of the present invention It is expected that the effect of preventing or treating allergic diseases can be achieved without side effects, and in particular, it can prevent allergies of the baby after birth, and also from the viewpoint of development and growth of the baby. Effectively promote its growth and development.
國內寄存資訊【請依寄存機構、日期、號碼順序註記】 Domestic registration information [please note according to the registration authority, date, number order]
無。 no.
國外寄存資訊【請依寄存國家、機構、日期、號碼順序註記】 Foreign deposit information [please note according to the country, organization, date, number order]
日本、獨立行政法人製品評價技術基盤機構 專利微生物寄存中心、2004/10/26、NITE BP-31 Japan, Independent Administrative Corporation Product Evaluation Technology Base Organization Patent Microbiology Deposit Center, 2004/10/26, NITE BP-31
<110> 明治股份有限公司 <110> Meiji Co., Ltd.
<120> 適合乳兒之抗過敏劑 <120> Anti-allergic agent suitable for infants
<130> <130>
<150> JP2015/205950 <150> JP2015/205950
<151> 2015-10-19 <151> 2015-10-19
<160> 2 <160> 2
<170> PatentIn version 3.2 <170> PatentIn version 3.2
<210> 1 <210> 1
<211> 20 <211> 20
<212> DNA <212> DNA
<213> 兩叉雙岐桿菌 <213> Bifidobacterium bifidum
<400> 1 <400> 1
<210> 2 <210> 2
<211> 19 <211> 19
<212> DNA <212> DNA
<213> 兩叉雙岐桿菌 <213> Bifidobacterium bifidum
<400> 2 <400> 2
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| US9795623B2 (en) | 2010-12-31 | 2017-10-24 | Abbott Laboratories | Methods for reducing the incidence of oxidative stress using human milk oligosaccharides, vitamin C and anti-inflammatory agents |
| CN103813796A (en) | 2011-07-22 | 2014-05-21 | 雅培制药有限公司 | Galactooligosaccharides for preventing injury and/or promoting healing of the gastrointestinal tract |
| US10639319B2 (en) | 2011-08-29 | 2020-05-05 | Abbott Laboratories | Human milk oligosaccharides for preventing injury and/or promoting healing of the gastrointestinal tract |
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| JP5273695B2 (en) * | 2005-03-03 | 2013-08-28 | 株式会社明治 | Allergy prevention and / or treatment agent containing bifidobacteria as an active ingredient |
| EP2251022A1 (en) * | 2009-05-11 | 2010-11-17 | Nestec S.A. | Non-replicating micro-organisms and their immune boosting effect |
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| US20180303883A1 (en) | 2018-10-25 |
| JPWO2017069167A1 (en) | 2018-10-25 |
| EP3366300A4 (en) | 2019-06-19 |
| AU2016341734A1 (en) | 2018-05-10 |
| US20190201459A1 (en) | 2019-07-04 |
| CN108289919A (en) | 2018-07-17 |
| WO2017069167A1 (en) | 2017-04-27 |
| CA3002509A1 (en) | 2017-04-27 |
| HK1254529A1 (en) | 2019-07-19 |
| EP3366300A1 (en) | 2018-08-29 |
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